Vioxx - Rofecoxib

Modified on 2009/10/14 21:51 by admin


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Vioxx, also known generically as rofecoxib, is a selective cox-2 inhibitor used to treat pain associated with arthritis. Physicians may also prescribe Vioxx, available in tablet and liquid form, to relieve minor pain, headaches and menstrual discomfort. Approved by the the U.S. Food and Drug Administration (FDA) in May 1999, Vioxx is made by Merck & Co.

On September 30, 2004, Merck & Co., Inc. announced a voluntary withdrawal of Vioxx (rofecoxib) from the U.S. and worldwide market due to safety considerations of an increased risk of cardiovascular events (including heart attack and stroke) in patients on Vioxx.

Numerous studies, including one sponsored by the drug's manufacturer, have found that Vioxx may increase a patient's risk of suffering a heart attack, stroke, or blood clot.   Minor side effects of Vioxx use may include upset stomach, dizziness, heartburn, vomiting and constipation.

Vioxx History


In August 2008 Merck & Co. established a settlement fund for the approximately 50,000 potential claimants eligible for benefits from Vioxx drug injury.  Users of Vioxx who experienced drug-related injuries further to taking Vioxx should expect to be compensated. The company reached asettlement agreement with the Vioxx plaintiffs in November 2007.   


Nearly three years after pulling Vioxx from the market, in November 2007 Merck committed to landmark settlements worth some $4.85 billion dollars.  The Vioxx settlement represents one of the the largest payouts ever by big pharma in a defective drug lawsuit, and will hopefully allow the victims of Vioxx and their families to achieve vindication and some measure of closure.  Ironically, the payouts represent for Merck less than one year's worth of the company's net profits.

The Institute for Safe Medication Practices and the Division of Public Health Sciences, Wake Forest University School of Medicine, conducted a longitudinal Adverse Events Reporting System Review of the U.S. FDA's most dangerous drugs in September 2007.  The study found Vioxx to be one of the most dangerous drugs on the market with some of the highest number of suspect drug deaths.  Vioxx was the fourteenth deadliest drug in the study, according to the FDA reports.  Over the eight years of the dangerous drug study, Vioxx was found to have been involved in over 900 deaths in an 8-year period.

Vioxx also represented a disproportionately high number of adverse drug event reports.  In the eight years of the study, over 7,700 serious medical events were reported to the FDA related to Vioxx that resulted in disability or that were otherwise serious enough to seek medical attention.


In February 2005, the Wall Street Journal reported that a safety committee monitoring Vioxx before its withdrawal had early data from a clinical trial indicating users could be at increased risk of heart problems after four months of use. The committee, which included a Merck employee, reportedly kept the trial going to see if Vioxx could reduce colon polyps.

Shortly after the release of the Wall Street Journal article, a whistleblower speaking to a FDA panel reviewing the safety of painkillers revealed that up to 10,000 additional Vioxx-related heart attacks may occur. The physician told researchers that patients involved in clinical trials are usually healthier than real world patients, which caused physicians to underestimate Vioxx's actual impact on users.

A study conducted by a U.S. private health insurance group has confirmed fears that cox-2 inhibitors cause serious cardiovascular events. In February 2005, Wellpoint Inc. released a study that found Bextra, Celebrex and Vioxx increase the risk of heart attack or stroke in users. According to the research, the risk of heart attack was 53 percent higher than normal for patients taking Bextra, 19 percent higher for those taking Celebrex and 23 percent higher for patients taking Vioxx. The study reportedly found no increase in cardiovascular events in patients taking traditional anti-inflammatory medications.

Concluding three days of meetings reviewing the safety of cox-2 inhibitors, advisers told FDA officials in February 2005 that Celebrex, Bextra and Vioxx, while posing an increased risk for cardiovascular events, should stay on the market because the drugs' benefits outweigh their potential dangerous side effects. The advisory panel voted 31-1 to keep Celebrex on the market, 17-13 to keep Bextra available to patients and favored Vioxx by a vote of 17-16. Vioxx is currently not for sale after being recalled in September 2004.


The makers of Vioxx received more damaging news in August 2004 when a FDA-funded study found that Vioxx increases the risk of heart attack and cardiac death more than Celebrex. The study, which was released at an epidemiologist conference, found that both high and low levels of the medication increase the risk for cardiovascular events. According to the study, patients taking the highest doses increase their risk of heart attack more than three-fold.

Merck & Co., Inc. withdrew Vioxx (rofecoxib) from the world market in September 2004 due to widespread safety concerns over the increased risk of cardiovascular events in patients taking the painkiller.

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See Also

  1. Arthritis Drugs
  2. Aseptic Meningitis: Overview
  3. Balance Problems: Overview
  4. Blood Clots
  5. Heart Attack Lawsuits
  6. Kidney Failure
  7. Liver Problems
  8. Stroke
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